DIA 2018 Global Annual Meeting

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-663-L04-P; CME 1.25; IACET 1.25; RN 1.25

Gene therapies and genetically modified organisms face special regulatory challenges for the conduct of clinical trials. This is particularly true for global trials that face a myriad of approval requirements in addition to the regulatory agency and ethics committee approvals. While some countries have a well defined regulatory framework addressing these products, other countries do not and the requirements may be less clear. With an increased emphasis on conducting global clinical trials the investigation of the diverse additional requirements becomes paramount for developing a time- and cost-effective regulatory strategy. The session will provide an overview of requirements for some global countries from an industry professional.

Learning Objectives

Recognize that gene therapies require special considerations and approvals in addition to those from the regulatory and ethical perspective; Analyze all required approvals that are critical for devising a global regulatory strategy; Apply a sound regulatory strategy for gene therapy products which is required for cost and time efficient trial approvals.

Chair

Kirsten Messmer

Speaker

Key Regulatory Requirements and Challenges: EU/US/Canada
Janet C. Rae, RAC

Successfully Operationalizing Gene Therapy Clinical Trials
Venkata Jaggumantri